Reported Sep 10, 2014 · Terminated
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411…
St Jude Medical Cardiac Rhythm Management Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St Jude Medical Cardiac Rhythm Management Division · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
- Lot codes and dates
- Serial Numbers
3,621 of 3,621 codes
100496210049631004964100496510049661004967100496810049691004970100497110049721004973100497410049751004976100497710049781004979100498010049811004982100498310049841004985100498610049871004988100498910049901004991100499210049931004994100499510049961004997100499810049991005000100500110050021005003100500410050051005006100500710050081005009100501010050111005139100514010051411005142100514310051441005145100514610051471005148
- Serial Numbers
- Amount recalled
- 51,492 units (27,396 units in US)
Where it was sold
- Nationwide
Why it was recalled
An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new St Jude Medical Cardiac Rhythm Management… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.